Implant Delivery Device

ABSTRACT

Devices and methods are disclosed for the delivery of a compressible implant into a bodily lumen. The delivery device includes an enlarged section that is configured to house the implant during delivery thereof into a patient. In certain embodiments, the implant is kept within the delivery device in a substantially uncompressed configuration prior to the delivery thereof.

FIELD OF THE INVENTION

The present invention relates to devices that are useful for thedelivery of compressible implants into a bodily lumen, and moreparticularly, to devices that may be used to deliver a compressibleimplant into a fallopian tube.

BACKGROUND

It is often desired or necessary for medical reasons to deliver animplant into a bodily lumen, such as a lumen within the vascular,urogenital, and gastrointestinal systems. For example, stents may bedelivered into any of these systems, embolic implants may delivered intoblood vessels, and occlusion implants may be delivered into thefallopian tubes for sterilization purposes.

An example of an occlusive implant that is placed within the fallopiantubes for sterilization purposes is the Adiana® Permanent Contraceptionsystem (Hologic, Inc., Marlborough, Mass.). To use this system, aflexible delivery catheter is passed through the vagina and cervix andinto each fallopian tube to deliver a low level of radiofrequencyenergy, followed by the delivery of a small, compressible occlusionimplant. Implants are usually placed in the uterotubal junction, thenarrowest part of the fallopian tubes. Such implants and procedures aredescribed, for example, in U.S. Pat. No. 7,220,259, which isincorporated herein by reference.

Compressible implants, including occlusion implants, embolics, andstents, are often made from polymeric materials that allow for thecompression of these implants into small profiles so that they may fitwithin the dimensions of their respective delivery devices. After thedelivery device is positioned to a target location within the bodilylumen, the implant is extruded or otherwise released from the deliverydevice such that it self-expands from its reduced, deliveryconfiguration into its intended expanded, working configuration. Theexpanded configuration may be necessary, for example, to apply forcesagainst the surrounding bodily lumen wall to thereby keep the implant atthe target location within the body.

Because many compressible implants are loaded into a delivery device atthe point of manufacture rather than at the point of use, they areconsequently kept in a reduced configuration within the confines of thedelivery device during sterilization, shipping, and storage. During suchtime, the materials used in such compressible implants may undergostress relaxation or other changes to mechanical properties that resultfrom being held in a reduced configuration. If kept in the reducedconfiguration for too long and/or at elevated temperatures; the implantmay not expand to a proper working configuration once released from itsdelivery device. The result is that many compressible implants have ashort permissible shelf life and temperature exposure limitations.

It is an object of the present invention to provide for delivery devicesand associated methods that allow for compressible implants to besterilized, shipped, and stored for extended periods of time and/or atelevated temperatures without adversely affecting their properties orworking function.

SUMMARY OF THE INVENTION

In one aspect, the present invention comprises a device for the deliveryof a compressible implant into the body of a patient.

In another aspect, the present invention comprises a kit that includes acompressible implant pre-loaded in a delivery device.

In yet another aspect, the present invention comprises a method oftreating a patient by delivering a compressible, implant into the bodyof a patient by using the delivery devices of the present invention.

In certain embodiments, the present invention includes a device for thedelivery of a compressible implant into the body of a patient. Thedelivery device comprises a proximal section, a distal section, and anintermediate section between the proximal and distal sections. Each ofthe proximal, distal, and intermediate sections comprise an innerdimension and an outer dimension and a continuous open space extendingwithin their inner dimensions. The device includes an opening in theproximal section and another opening in the distal section, each ofwhich provides access to the continuous open space. The inner and outerdimensions of the distal section are both less than the respective innerand outer dimensions of the intermediate section. The intermediatesection is configured to house the compressible implant prior to itsdelivery, during which time a cross-sectional dimension of thecompressible implant is greater than the inner dimension of the distalsection. The device further includes a contact member configured tocontact the compressible implant within the intermediate section, and toapply a force to the compressible implant so that it moves from theintermediate section into the distal section and through the opening inthe distal section.

DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a side view, and FIG. 1 b an end view, of a delivery devicein accordance with an embodiment of the present invention.

FIG. 2 is a cross-sectional view of a delivery device in accordance withan embodiment of the present invention.

FIG. 3 is an occlusive implant that may be delivered into a patient,using the delivery devices of the present invention.

FIG. 4 is a cross-sectional view of a delivery device in accordance withan embodiment of the present invention in which a compressible implantis being advanced into a distal section of the delivery device.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention provides for the delivery of compressible implantsusing delivery devices that allow such implants to be kept in asubstantially uncompressed configuration prior to delivery into apatient. Because the compressible implants are kept in a substantiallyuncompressed configuration, they can be sterilized, shipped and storedfor relatively long time periods and at high temperatures whilemaintaining the ability to expand to a proper working configuration oncedelivered into a patient. In contrast, compressible implants that aresterilized, shipped and stored in substantially compressedconfigurations within the confines of conventional implant deliverydevices have short permissible shelf lives and temperature exposurelimitations in order to minimize the risk that they will undergo stressrelaxation prior to delivery into a patient, and therefore not expand toacceptable working configurations.

The present invention is described with specific reference to an,occlusive implant that is placed within the fallopian tubes forsterilization purposes. It should be recognized, however, that thedevices and methods of the present invention are equally applicable toany compressible implant that must be compressed to facilitate deliveryinto a patient and then expand into a proper working configuration.Non-limiting examples of such implants include self-expanding polymericstents, filters, and polymeric embolics and other occlusive implants.

In one embodiment, the present invention includes a device for thedelivery of a compressible implant into a bodily lumen. As shown in theside view of FIG. 1 a, the delivery device 100 generally comprises aproximal section 110, a distal section 130, and an intermediate section120 between the proximal and distal sections 110, 130. The distalsection 130 is intended to be insertable into the bodily lumen, andterminates in a distal tip 131. The proximal section 110 terminates in aproximal end 111, which is intended to extend outside of the body duringuse. As shown in the end view of FIG. 1 b, the outer configuration ofdelivery device 100 and its sections are preferably cylindrical.

As seen in cross section in FIG. 2, each of the proximal, distal, andintermediate sections 110, 130, 120 is characterized by a respectiveinner dimension, preferably a diameter, noted as dimensions 112, 132,and 122. Each section is also characterized by a respective outerdimension 113, 133, and 123, preferably a diameter, the size of which issum of each respective inner dimension 112, 132, and 122 and twice thewidth of the side wall 105 of each respective section. In allembodiments of the invention, the inner and outer dimensions 132, 133 ofthe distal section 130 are less than the respective inner and outerdimensions 122, 123 of the intermediate section 120. In addition, theinner dimension of the proximal section 112 is preferably less than theinner dimension of the intermediate section 122. The outer dimension ofthe proximal section 113 may be less than the outer dimension of theintermediate section 123, as shown in FIGS. 1 and 2, or is preferablyabout the same size as the outer dimension of the intermediate section123.

The delivery device 100 preferably includes a transition section 140extending between the intermediate section 120 and the distal section130. The transition section 140 is characterized by inner and outerdimensions 141, 142 that preferably gradually decrease from therespective inner and outer dimensions 122, 123 of the intermediatesection to the respective inner and outer dimensions 132, 133 of thedistal section.

The delivery device 100 includes an opening 114 in the proximal section,and another opening 134 in the distal section to provide access to acontinuous open space 150 that extends within the inner diameters of theproximal, distal, and intermediate sections. While the opening 134 ispreferably on a side wall of the distal section 130 as shown in FIG. 2,it is alternatively located at the tip of the distal end 131. Locatingthe opening 134 on the side wall instead of the tip of the distal end131 allows the tip to be rounded, or preferably in the form of a “balltip” to minimize trauma to tissue as the delivery device 100 is advancedthrough tissue or within a bodily lumen. The opening 114 in the proximalsection allows for the loading of a compressible implant 160 into thedelivery device 100, while the opening 134 in the distal section allowsfor the delivery of the compressible implant 160 into the patient.

In the embodiment shown in FIG. 2, the compressible implant 160 is anocclusive implant that is intended to be placed within the fallopiantubes for sterilization purposes. In a preferred embodiment, the implant160 comprises an inner core 161 and an outer porous portion 162 to forma porous plug, as shown in FIG. 3. The inner core and outer porousportion 161, 162 comprise any suitable material, such as silicone. Thecross-sectional shape of the implant 160 may be round, oval, or anyother suitable shape. In a preferred embodiment, the implant 160 iscylindrical and has an uncompressed diameter of between about 1.0 mm and2.0 mm, preferably about 1.6 mm. The diameter of the inner core 161 ispreferably between about 0.25 mm and 0.5 mm.

The outer porous portion 162 of implant 160 is preferably formed as areticulated foam having an interconnected porous structure with a poresize in the range of 1-20 microns. The porous structure of the outerporous portion 162 contributes to the compressible nature of the implant160 and helps to facilitate tissue ingrowth into the implant 160following delivery into the patient. Silicone foam is preferred as thematerial for the outer porous portion 162, and may be formed using theprocedure set forth in U.S. Pat. No. 5,605,693, which is incorporatedherein by reference. In addition to silicone, examples of othermaterials that may be used to make the outer porous portion 162 includepolytetrafluoroethylene (PTFE), acrylic copolymers, cellulose acetate,polyethylene (including HDPE), and polyester.

The intermediate section 120 of the delivery device 100 is configured tohouse the compressible implant 160 prior to delivery of the implant intothe patient. The uncompressed diameter of the implant 160 issignificantly larger than the inner diameter 132 of the distal section130 of delivery device 100. According to preferred embodiments of thepresent invention, however, the uncompressed diameter of the implant 160is about the same as, or slightly larger than, the inner diameter 122 ofthe intermediate section 120 such that the implant 160 remains in asubstantially uncompressed configuration prior to its delivery into thepatient. According to embodiments of the present invention,“substantially uncompressed configuration” means that the implant 160 isheld within the inner diameter 122 of the intermediate section 120 to adimension that is not less than about 70%, preferably not less thanabout 80%, more preferably not less than about 90%, and most preferablynot less than about 95%, of its as-manufactured uncompressed diameter.It is preferred that the inner diameter 122 of the intermediate section120 is at least marginally less than the uncompressed diameter of theimplant 160 so that the implant is held in place by the walls of theintermediate section 120 during sterilization, shipping, and storage.It, should be appreciated, however, that the present invention includesembodiments in which the inner diameter 122 of the intermediate section120 is larger than the uncompressed diameter of the implant 160.

As non-limiting examples of dimensions of various aspects of the presentinvention, for a compressible implant having a diameter of about 1.6 mm,the length of the distal section 130 is about 10-15 mm to facilitateplacement of the implant 160 into the uterotubal junction. The innerdimension 132 of the distal section is about 0.9 mm and the outerdimension 133 is about 1.1-1.4 mm. The inner dimension 122 of theintermediate section 120 is about 1.2-1.6 mm, and the outer dimension123 is about 1.3-1.7 mm to facilitate introduction through a 5 Frenchhysteroscope, as is described below.

The delivery device 100 preferably includes one or more electrodes, suchas ring electrodes 170, mounted on the length of the distal section 130.Electrodes 170 are made from any suitable electrically conductivematerial such as stainless steel, copper, nickel-cobalt alloys,platinum, titanium, and nickel-titanium alloys. Electrodes 170 areconfigured for the delivery of radiofrequency (RF) energy or othersuitable energy form, such as microwave energy, to surrounding tissue aspart of a procedure that includes the delivery of implant 160 to thebody of a patient. The energy may be supplied by any one of numerousenergy generators available commercially.

The delivery device 100 also preferably includes a visual marker 180,such as a band optionally comprising a radiopaque material, placedaround the distal section 130. Examples of radiopaque marker bandmaterials include tungsten, gold, and platinum, as well as polymers thatinclude barium sulfate, bismuth subcarbonate, bismuth trioxide, orbismuth oxychloride. The radiopaque marker 180 optionally includes oneor more sensors to detect when the distal section 130 is in contact withtissue, as are known in the art. For example, the radiopaque marker 180may include electrically conductive wires (not shown) that are inelectrical connection with surrounding tissue and extend through theopening 114 in the proximal section 110. Current is passed through thewires, with a reduction in resistance indicating contact with tissue.

In the example of implant delivery for female sterilization, thecompressible implant 160 is loaded into the intermediate section 120 ofthe delivery device 100 by insertion into the proximal section 110 usinga funnel followed by advancing the implant using a push rod or similarinstrument. In one embodiment, multiple compressible implants 160 areloaded into the intermediate section 120 for delivery into the body of apatient. The loaded delivery device is then packaged, sterilized usingethylene oxide gas, for example, and then shipped and stored until use.The inventors expect that the use of the delivery device of the presentinvention has the potential to increase the shelf life of an occlusiveimplant 160 to five years or longer.

When ready for use, the delivery device 100 is removed from itspackaging materials and, in this example, is inserted through thevagina, through the cervix, and into the uterus. Such insertion may bedone under x-ray guidance, sonographically, hysteroscopically, or in theabsence of visualization, and may be conducted under general and/orlocal anesthesia. The transition section 140 is preferably sized suchthat it abuts the ostium of the fallopian tube such that the deliverydevice 100 cannot advance any further into the patient. The length ofthe distal section 130 is likewise sized so that the implant 160 isdelivered to a desired location within the fallopian tube, given thatthe transition section 140 is in contact with the ostium. Once at thislocation, in a preferred embodiment, RF energy is delivered to theelectrode(s) 170, which results in the ablation and consequentconstriction of the tissue around the distal section 130.

Subsequent to tissue ablation, or alternatively in the absence of anytissue ablation, the implant 160 is extruded from the delivery device100 by the relative movement between a contact member 190 and thedelivery device 100. For example, the contact member 190 is insertedinto the proximal section 110 to contact the implant 160 and push itinto the distal section 130, as shown in FIG. 4. Alternatively, thecontact member 190 is held stationary, and the delivery device 100 iswithdrawn in a proximal direction such that the contact member forcesthe implant 160 to enter into the distal section 130. In either case,the implant 160 moves through the distal section 130 and exits thedelivery device 100 through the opening 134 and into the patient. Thecontact member 190 is made from any suitable material that providessufficient column stiffness to provide a force to the implant 160 suchthat it enters the distal section 130 and exits the opening 134.Examples of such materials include tubes or wires made from stainlesssteel or nitinol. In a preferred embodiment, the distal end of thecontact member 190 is coated with polyurethane or other polymericmaterial to minimize the risk of damaging the implant 160 upon theapplication of force by the contact member 190.

The deployed implant 100 is left within the patient to provide permanentocclusion of the fallopian tube. The process is repeated for eachfallopian tube. The implant 100 is maintained in place by theconstrictive action of the surrounding tissue. As an aid to long termretention, the implant is porous as previously discussed to facilitatetissue ingrowth.

The delivery device 100 of the present invention is manufactured usingknown fabrication techniques and materials. For example, the deliverydevice 100 may be manufactured by extruding two polymeric tubes withflared and tapered ends, and then joining the flared ends to define theintermediate section 120. Such tubes may be made from any suitablematerial, such as; for example, polyurethane or polyether block amidesuch as PEBAX® (Arkema France Corporation, Colombes, France). In apreferred embodiment, an outer jacket of a relatively stiff material,such as polyetheretherketone, is applied over the proximal section 110,and preferably over the intermediate section 120, as an extrusion.

The present invention provides for the delivery of compressible implantsusing delivery devices that allow such implants to be kept in asubstantially uncompressed configuration prior to delivery into apatient, and thereby enables an extended shelf life for such implantswithout severe temperature, limitations. Although the present inventionis described with specific reference to an occlusive implant that isplaced within the fallopian tubes for sterilization purposes, it isintended that the present invention be applicable to any compressibleimplant that must be compressed to facilitate delivery into a patientand then expand into a proper working configuration. Furthermore, itwill be apparent to those skilled in the art that various modificationsand variations can be made in the structure and methodology of thepresent invention. It is intended that the present invention cover themodifications and variations of this invention provided that they comewithin the scope of the appended claims and their equivalents.

1. A device for the delivery of a compressible implant into a bodilylumen, the device comprising: a proximal section, a distal section, andan intermediate section between said proximal and distal sections, eachof said proximal, distal, and intermediate sections comprising an innerdiameter and an outer diameter and a continuous open space extendingwithin the inner diameters of the proximal, distal, and intermediatesections, a first opening in said proximal section and a second openingin said distal section, each of said first and second openings providingaccess to the continuous open space; and a contact member within theinner diameter of said proximal section; wherein the inner diameter ofsaid distal section is less than the inner diameter of said intermediatesection, the outer diameter of said distal section is less than theouter diameter of said intermediate section; the intermediate section isconfigured to house the compressible implant prior to delivery of thecompressible implant into the bodily lumen; a cross-sectional dimensionof the compressible implant is greater than the inner diameter of saiddistal section when the compressible implant is housed within saidintermediate section; and said contact member is configured to contactthe compressible implant within said intermediate section, and to applya force to the compressible implant so that the compressible implantmoves from said intermediate section into said distal section andthrough said second opening.
 2. The device of claim 1, wherein theintermediate section is configured such that the implant is in asubstantially uncompressed configuration when housed within theintermediate section.
 3. The device of claim 1, wherein the innerdiameter of said intermediate section is greater than the inner diameterof said proximal section.
 4. The device of claim 1, further comprising atransition section extending between said intermediate section and saiddistal section, said transition section comprising an inner diameter andan outer diameter that decrease from the respective inner and outerdiameters of said intermediate section to the respective inner and outerdiameters of said distal section as the transition section extends fromsaid intermediate section to said distal section.
 5. The device of claim1, further comprising an electrode on said distal section.
 6. The deviceof claim 5, wherein said electrode is a ring electrode.
 7. The device ofclaim 6, wherein said device comprises a plurality of ring electrodes onsaid distal section.
 8. The device of claim 1, wherein said distal endterminates in a ball tip.
 9. The device of claim 8, wherein said secondopening is positioned on a side wall of said distal section.
 10. Thedevice of claim 1, wherein the implant comprises silicone.
 11. Thedevice of claim 10, wherein the implant is a substantially porous plug.12. The device of claim 1, further comprising a visual marker on saiddistal section.
 13. The device of claim 12, wherein said visual markercomprises a band placed around said distal section.
 14. The device ofclaim 1, further comprising a sensor on said distal section.
 15. Thedevice of claim 14, wherein said sensor is capable of sensing whendistal section is in contact with tissue.
 16. A device for the deliveryof a compressible contraceptive implant into a fallopian tube, thedevice comprising: a proximal section, a distal section, and anintermediate section between said proximal and distal sections, each ofsaid proximal, distal, and intermediate sections comprising an innerdiameter and an outer diameter and a continuous open space extendingwithin the inner diameters of the proximal, distal, and intermediatesections, a first opening in said proximal section and a second openingin said distal section, each of said first and second openings providingaccess to the continuous open space; and a contact member configured toextend within the inner diameter of said proximal section; wherein theinner diameter of said distal section is less than the inner diameter ofsaid intermediate section, the outer diameter of said distal section isless than the outer diameter of said intermediate section and the innerdiameter of said intermediate section is greater than the inner diameterof said proximal section; the intermediate section is configured tohouse the contraceptive implant prior to delivery of the compressibleimplant into the bodily lumen; a cross-sectional dimension of thecontraceptive implant is greater than the inner diameter of said distalsection when the contraceptive implant is housed within saidintermediate section; and said contact member is configured to contactthe contraceptive implant within said intermediate section, and to pushthe compressible implant into said distal section and through saidsecond opening into the fallopian tube.